Packaged bag system with identification tags

ABSTRACT

The invention includes an assembly including a package and a bag system for collecting a biological fluid, in particular blood. The system may be confined in a sterile fashion in the package. The system may include a fluid collecting bag and a device for sampling the fluid to be collected which includes at least one sampling receptacle associated dissociably with the system. The collecting bag and the sampling receptacle are each provided with an identification tag which includes information making it possible, after dissociation of the receptacle from the bag system, to unequivocally establish that the sampling receptacle and the collecting bag come from the same bag system.

PRIORITY CLAIM

[0001] The present invention claims priority under 35 U.S.C. §119(d) toFrench Patent Application Serial No. 03/02033, filed Feb. 19, 2003.

FIELD OF THE INVENTION

[0002] The invention concerns an assembly including a package and asystem of bags for collecting a biological fluid as well as a method ofmanufacturing such an assembly. For reasons of asepsis, the bag systemis normally confined in a sterile fashion in the package at the time ofmanufacture, the package being arranged so as to be opened prior to theuse of the system.

BACKGROUND

[0003] The invention may be used when a biological fluid, typicallywhole blood, is collected from the donor in a collecting bag. To dothis, the bag system includes, in closed circuit, a device for drawingthe blood which is in fluid communication with at least one bloodcollecting bag. In addition, the system includes a device for samplingthe blood which is intended to receive some of the blood taken off, thedevice including at least one sampling receptacle which is associateddissociably with the system.

[0004] The use of such a sampling device makes it possible to obtain, ineach receptacle, a sample of blood, the receptacles then being able tobe dissociated from the system in order to analyse the samples, inparticular in order to carry out serology, virology and a cell count orhematocrit.

[0005] In particular, the bag system can be used by drawing the firstmillilitres of blood in the sampling device, which has a certain numberof advantages. Firstly, this reduces the risk of contamination stemmingfrom the presence of bacteria or other foreign substances on the skin ofthe donor because the first millilitres of blood collected, to whichthis contamination relates, are sent into the sampling device ratherthan into the collecting bag. Secondly, this makes it possible toproduce the samples before the bag is completely filled and consequentlynot to waste any time. Finally, at the time the blood is collected theloss of the volume of blood for the donor is compensated for by theaddition of plasma, causing the haematocrit reading of the blood to beanalysed to be lower if the sampling device is filled after thecollecting bag. Consequently the count would be inaccurate.

[0006] One problem which is posed by such a system is that of thetraceability of the samples of blood contained in the receptacles.Because the purpose of the tests carried out on the samples is to knowthe characteristics of the blood collected, it is essential to be ableto know the source of the samples. Otherwise, incorrect information maybe associated with blood contained in a collecting bag, which can haveserious consequences when the blood is transfused to a patient.

[0007] In current practice, the resolution of this problem falls uponthe user of the bag system, who must identify, for example by means oflabels, the sampling receptacles which are used to sample the bloodcollected in each bag system. To this end, the user must place a labelon the collecting bag and on each receptacle, the labels containinginformation making it possible to know the source of the sample. Inparticular, these labels contain common information which make itpossible to link the sampling receptacles to the collecting bagcontaining the sampled blood.

[0008] This practice is not satisfactory because it leaves room for ahandling error on the part of the user, an error which is all the moreprobable when the user is handling a large number of bag systems.

SUMMARY

[0009] The invention includes a bag system with which at least onesampling receptacle is associated dissociably. An identification tag isdisposed, prior to the packaging of the bag system, on each receptacleand on the collecting bag. The identification tag includes informationfor unequivocally establishing that the receptacle or receptacles andthe sampling bag come from the same bag system.

[0010] By integrating the identification tag at the time of manufactureof the packaged bag system, the user merely has to open the package inorder to use the bag system, without worrying about the traceability ofthe samples obtained.

[0011] To this end, and according to a first aspect, the inventionconcerns an assembly including a package and a bag system for collectinga biological fluid, in particular blood. The said system may be confinedin a sterile fashion in the package, which is arranged so as to be ableto be opened prior to the use of the system. The system may include afluid collection device which is in fluid communication with at leastone fluid collecting bag, and a device for sampling the fluid to becollected which includes at least one sampling receptacle associateddissociably with the system. The collecting bag and the samplingreceptacles are each provided with an identification tag which includesinformation making it possible, after dissociation of the receptaclefrom the bag system, to unequivocally establish that the samplingreceptacle and the collecting bag come from the same bag system.

[0012] According to a second aspect, the invention concerns a method ofmanufacturing such an assembly, the method including, prior to thepackaging of the bag system, providing the collecting bag and eachreceptacle with an identification tag which includes information makingit possible, after dissociation of the receptacle from the bag system,to unequivocally establish that the sampling receptacle and thecollecting bag come from the same bag system.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Other objects and advantages of the invention will emerge duringthe following description, given with reference to the accompanyingdrawings, in which:

[0014]FIG. 1A depicts schematically a bag system for collecting bloodwhich includes a sampling device according to a first embodiment;

[0015]FIG. 1B depicts schematically a bag system for collecting theblood and separating the blood components which includes a samplingdevice according to a second embodiment;

[0016]FIG. 2 depicts schematically the transfer portion of the samplingdevice depicted in FIG. 1A;

[0017]FIGS. 3A and 3B depict schematically the transfer device of FIG. 2in which a sampling receptacle is disposed respectively in a position ata distance and in a transfer position; FIG. 3C is a representationsimilar to FIG. 3B showing a variant embodiment of the transfer device;

[0018]FIG. 4 depicts schematically a bag system for collecting the bloodwhich includes a sampling device provided with several transfer portionaccording to FIG. 2;

[0019]FIGS. 5A to 5E depict schematically the transfer portion of thesampling device of FIG. 2, respectively in front view, in perspective,in profile, in plan view and in transverse section, the samplingreceptacles being in the standby position;

[0020]FIGS. 6A and 6B depict schematically the transfer device of FIG. 5according to a variant embodiment, respectively in front view andprofile, the receptacles being in the standby position; FIG. 6C is aview similar to FIG. 6B in which a receptacle is in the transferposition;

[0021]FIG. 7 depicts a bag system for collecting the blood whichincludes a sampling device according to a third embodiment;

[0022]FIGS. 8A and 8B depict schematically an assembly including apackage in which a bag system respectively according to FIGS. 4 and 1Bis confined in a sterile fashion.

DETAILED DESCRIPTION

[0023]FIGS. 1A, 1B and 7 depict bag system 1 including a device forcollecting the a biological fluid from a donor and at least onecollecting bag 2 intended to receive the fluid collected. In aparticular embodiment, the fluid may be blood.

[0024] The collection device may consist in particular of needle 3allowing access to the vein of the donor and cap 4 protecting needle 3.In addition, needle protector 5 may be placed slidably on first tube 6.First tube 6 provides fluid communication between collecting bag and thecollection device.

[0025] Bag system 1 also includes a sampling device, which is in fluidcommunication with collecting bag 2 by way of first tube 6 and secondtube 7, which are connected at first connector 8 by a three-wayjunction.

[0026] In the embodiments depicted, the sampling device includessampling bag 9 which is connected to the downstream end of second tube7. The terms downstream and upstream are defined with respect to thedirection of circulation of the blood, from the collection device to thebags and the sampling device.

[0027] The sampling device also includes a transfer device 10 fortransferring the fluid which is in fluid communication with collectingbag 2 by way of first tube 6 and second tube 7, and possibly third tube11 connected to second tube 7 at second connector 12 in the form of athree-way junction.

[0028] As depicted in FIG. 2, transfer device 10 includes hollow guide13, open at front part 14 to allow the introduction of samplingreceptacle 15, and hollow needle 16 passing through rear part 17 ofguide 13, so that the downstream part of needle 16 extends inside guide13 and an upstream part of needle 16 extends outside guide 13. Thedownstream segment of hollow needle 16 is enclosed in elastic sheath 18.The upstream segment of hollow needle 16 enables the transfer device tobe connected with bag system 1. A fluid communication device or tube isthen connected to the upstream segment.

[0029] First clamp 19 and second clamp 20 can be situated respectivelyon first tube 6, downstream of connector 8, and on second tube 7. Clamps19 and 20 make it possible to orient the flow of fluid collected, eitherto sampling bag 9, where first clamp 19 is closed while second clamp 20is open, or to collecting bag 2, where second clamp 20 is closed whilefirst clamp 19 is open.

[0030] Sampling receptacle 15 is filled with the collected bloodcontained in sampling bag 9 when receptacle 15 is placed in the transferposition, namely when the downstream end of needle 16 is in fluidcommunication with the inside of receptacle 15, by perforation ofclosure element 21 of receptacle 15.

[0031] Circuit openers can be provided within bag system 1. Inparticular circuit opener 22 may be situated on second tube 7 close tofirst connector 8.

[0032] As depicted in FIG. 1B, in order to perform steps of filtrationand separation as well as the removal of leukocytes with regard to thevarious constituents of the blood, collecting bag 2 may be in fluidcommunication, by way of fourth tube 23, with satellite bags 24 a-c.Leukoreduction filter 25 is situated between collecting bag 2 andsatellite bag 24 a. Satellite bag 24 a may be in fluid communicationwith one or more other satellite bags. For example satellite bag 24 amay be in fluid communication with two other satellite bags 24 b, c.Clamp 26 may be provided on fourth tube 23 between collecting bag 2 andleukoreduction filter 25. According to one embodiment, satellite bags 24a-c may be provided with identification tag 35.

[0033] According to a first embodiment, transfer device 10 is providedwith a device for associating sampling receptacle 15, as depicted inFIG. 2. The association device includes first 27 and second 28 set ofprojections distributed longitudinally on the internal surface of guide13, respectively close to needle 16 of the guide and close to front part14 of guide 13. The projections are arranged so as to be deformable whensliding receptacle 15 inside guide 13 so as to allow a reversibleassociation of receptacle 15 inside guide 13. The projections allow asliding of receptacle 15 inside guide 13 between a standby position(FIG. 3A) at a distance from needle 16 and the transfer position (FIG.3B).

[0034] As depicted in FIGS. 2, 3A and 3B, the projections are flexible,in particular elastic, and are reversibly deformable from a positioninclined forwards towards a position inclined towards the rear bycontact of receptacle 15 when it slides inside guide 13 in the front torear direction. When receptacle 15 is removed from guide 13, theprojections incline from rear to front so that the receptacle is notdissociated from its closure element 21. In the embodiment depicted,sampling receptacle 15 includes closure element 21 whose diameter isgreater than that of the body of receptacle 15 and it is during thepassage of closure element 21 that the projections incline in onedirection or the other.

[0035] According to a variant depicted in FIG. 3C the projections infirst set 27 situated close to needle 16 are breakable under the effectof the sliding of receptacle 15 placed in the transfer position. Theperforation of closure element 21 is thus visible and the user can checkthat the perforation did not take place prior to the taking of samples.

[0036] As depicted in FIG. 4, several transfer devices 10, in each ofwhich a sampling receptacle 15 is associated dissociably, may beconnected to bag system 1 by way of second tube 7 or third tube 11,connected to second tube 7 by second connector 12. Dissociablyassociating several receptacles 15 with several transfer devices 10 hasadvantages, firstly a saving in time for the person responsible for thecollecting because he or she does not have to put receptacle 15 in placein transfer device 10 and secondly a reduction in the risk of error intraceability of the donations, because this makes it possible to fixlabels prior to the taking of samples, in particular at the time ofmanufacture.

[0037] According to a second embodiment, the association device isarranged so as to be able to support several receptacles 15 at adistance from guide 13 in a standby position and their sequentialguiding in guide 13, as depicted in FIGS. 1B and 5A to 5E.

[0038] The association device and the transfer device 10 may beassociated by clipping or welding or can be moulded in one and the samepiece.

[0039] The association device may include housing 29 associated withguide 13. Housing 29 is provided with skirt 30 in which closure element21 of receptacles 15 is introduced to allow longitudinal sliding ofreceptacles 15 in housing 29 towards guide 13. The internal wall ofskirt 30 is provided with projection 31 intended, by interaction withclosure elements 21, to prevent the transverse withdrawal of receptacles15 from housing 29.

[0040] Skirt 30 includes an open end disposed opposite a scallop formedin the guide, and an opposite closed end. In the other axis, a firstopen end is disposed opposite another end which is open so that the bodyof receptacle or receptacles 15 extends beyond housing 29.

[0041] At the time of manufacture, sampling receptacles 15 areintroduced into guide 13 through its open front part 14 so that closureelement 21 is situated level with groove 32 in housing 29 so that it canbe slid therein.

[0042] Cap 33 is then placed on guide 13, making it possible to holdreceptacles 15 in housing 29 until samples are taken by the user ofsystem 1.

[0043] The housing can be of variable size so as to contain from two toten receptacles 15. The number of receptacles 15 used varies accordingto the legislation, in France in particular five receptacles 15 are usedfor carrying out normal analyses.

[0044] When samples are taken, the person responsible for the samplingremoves cap 33 from guide 13, makes receptacles 15 slide as far as guide13, and then introduces them so that, by perforation of closure element21 of receptacle 15, the downstream end of needle 16 is in fluidcommunication with the inside of receptacle 15. After receptacle 15 hasbeen filled, the user withdraws it from guide 13. In one exampleembodiment, cap 33 may be provided with a tamper-evident element, suchas a tongue which is broken on first opening, so as to be able toidentify the first manipulation of cap 33.

[0045] According to a variant, depicted in FIGS. 6A to 6C, transferdevice 10 can slide on the association device, so that it can be placedlevel with each receptacle 15. When transfer device 10 is placed levelwith receptacle 15, the user may then move the transfer device 10transversely so that closure element 21 is perforated by needle 16. Sothat transfer device 10 may slide on the association device, twoopposite scallops are then formed in guide 13.

[0046] As depicted in FIG. 1B, transfer device 10 associating severalsampling receptacles 15 may be connected to bag system 1 by way ofsecond tube 7 and possibly third tube 11.

[0047] According to a third embodiment, depicted in FIG. 7, the samplingreceptacle or receptacles may be flexible, preformed and connected to atube of the bag system, in particular to second tube 7.

[0048] The sampling receptacle or receptacles 15 are filled,simultaneously or successively, with the collected blood contained insampling bag 9.

[0049] Filling takes place by mechanical pressure on sampling receptacle15, the air contained in preformed receptacle 15 is driven into samplingbag 9, while the blood contained in bag 9 is driven into receptacle 15.

[0050] After samples are collected, sampling receptacle 15 ishermetically welded and detached from bag system 1.

[0051] A septum 34 may be provided on the end of receptacle 15 oppositeto the end where the welding is carried out. In this way, after welding,one or more sampling receptacles 15 compatible with automatic analysiscontrollers are obtained. In order to perform a certain number ofanalyses, receptacle 15 may then be placed in a receptacle of theautomatic controller, and a needle of the automatic controller piercesseptum 34.

[0052] With known bag systems for collecting blood, the personresponsible for the collecting must, by way of some mark, identifycollecting bag 2 and sampling receptacle or receptacles 15 correspondingto one and the same donation.

[0053] According to the invention, the possibility of error intraceability of these donations is considerably reduced because, asdepicted in FIGS. 8A and 8B, sampling receptacle or receptacles 15 andcollecting bag 2 are dissociably associated at the time of manufacture.In addition, at the time of manufacture, collecting bag 2 and samplingreceptacle or receptacles 15, as well as any satellite bags 24 a-c, areeach provided with an identification tag 35, for example a self-adhesivebar code label, which includes information making it possible, afterdissociation of the receptacles from bag system 1, to unequivocallyestablish that sampling receptacle 15 and collecting bag 2, as well asany satellite bags 24 a-c, come from the same bag system 1. Bag system 1according to the invention may be packaged in flexible transparentpackage 36. Bag system 1 and package 36 thus form an assembly.

[0054] The method of manufacturing such an assembly makes provision,prior to the packaging of bag system 1, for providing collecting bag 2and each receptacle 15 with an identification tag which includesinformation making it possible, after dissociation of the receptaclefrom bag system 1, to unequivocally establish that sampling receptacle15 and collecting bag 2 come from the same bag system 1. In an exampleembodiment where label 35 is provided with a bar code, the bar code maybe printed on label 35 subsequent to its placement.

[0055] According to a first embodiment, the method includes disposingsterilised bag system 1 in package 36 and then may include pasteurisingthe whole.

[0056] According to a second embodiment, the method includes disposingbag system 1 in package 36 and then sterilising the whole.

[0057] According to a third embodiment, the method includes sterilisingthe bag system without receptacles 15, associating receptacles 15 withthe bag system, packaging the system and then possibly pasteurising thewhole. This embodiment is particularly adapted to the case wheresampling receptacles 15 contain reagents sensitive to the sterilisationstep. Moreover, closure elements 21 for sampling receptacles 15 may alsobe sensitive to the sterilisation step.

1. An assembly comprising: a package; and a bag system for collecting abiological fluid including: a collection device; a collection bag influid communication with the collection device; a sampling device havingat least one sampling receptacle associated dissociably with the system;and at least two identification tags, one on the collection bag and oneon the sampling receptacle wherein the tags allows the establishment,after their dissociation, that both the collection bag and receptacleoriginated from the same bag system, and wherein the bag system isconfined in a sterile fashion in the package, which is arranged so as tobe able to be opened prior to the use of the system.
 2. The assembly ofclaim 1, further comprising the collection bag in fluid communicationwith the collection device through a first tube to which the samplingdevice is in fluid communication through a second tube.
 3. The assemblyof claim 2, wherein the sampling device further comprises a sampling bagconnected to a downstream end of the second tube.
 4. The assembly ofclaim 1, wherein the sampling device further comprises a transferringdevice operable to transfer fluid from the bag system to a samplingreceptacle.
 5. The assembly of claim 4, wherein the transfer devicefurther comprises: a hollow guide open at a front part to allowintroduction of the sampling receptacle; and a hollow needle in fluidcommunication with the bag system, wherein the hollow needle passesthrough a rear part of the guide so that a downstream part of the needleextends inside the guide and an upstream part of the needle extendsoutside the guide, and wherein the hollow needle is operable toperforate the closure element of the receptacle, placing the downstreampart of the needle inside the receptacle.
 6. The assembly of claim 5,wherein the guide further comprises an association device operable toallow a reversible association of the receptacle inside the guide andsliding of the receptacle inside the guide between a standby position ata distance from the needle and a transfer position.
 7. The assembly ofclaim 6, wherein the association device further comprises a first andsecond set of projections distributed longitudinally on an internal faceof the guide, wherein the projections are arranged so as to bedeformable by sliding the receptacle inside the guide, and wherein theprojections are arranged so as to permit a reversible association of thereceptacle inside the guide and the sliding of the receptacle inside theguide between a standby position at a distance from the needle and thetransfer position.
 8. The assembly of claim 7, further comprising aplurality of transfer devices, each having a receptacle associated in adissociable fashion and each in fluid communication with the bag systemthrough the second tube or a third tube.
 9. The assembly of claim 6,further comprising the association device operable to support at leasttwo receptacle in the standby position and to allow their sequentialguidance into the guide.
 10. The assembly of claim 1, further comprisinga tube connecting the sampling device to the bag system, wherein thetube is weldable and breakable, and wherein an inlet orifice of at leastone receptacle is connected to a downstream end of the tube.
 11. Theassembly according to claim 10, further comprising a flexible samplingreceptacle.
 12. The assembly of claim 1, wherein the identification tagfurther comprises a label provided with a bar code, the label placed onthe collecting bag and each sampling receptacle.
 13. The assembly ofclaim 1, further comprising a flexible, transparent package.
 14. Theassembly of claim 1, further comprising a fourth tube in fluidcommunication with the collection bag and at least one satellite bag,wherein the satellite bag is also provided with an identification tag.15. A method of manufacturing an assembly comprising: placing anidentification tag on at least a collection bag and at least onesampling receptacle, wherein the collection bag and sampling receptacleform part of one bag system, placing the bag system in packaging,wherein wherein the tags allows the establishment, after theirdissociation, that both the collection bag and receptacle originatedfrom the same bag system.
 16. The method of claim 15, furthercomprising: sterilizing the bag system; and placing the bag system inthe packaging.
 17. The method of claim 15, further comprisingpasteurizing the bag system and the packaging after placement of the bagsystem in the packaging.
 18. The method of claim 15, further comprisingsterilizing the bag system and the packaging after placement of the bagsystem in the packaging.
 19. The method of claim 15, further comprising:sterilizing the bag system absent the receptacle; and associating thereceptacle with the bag system.
 20. The method of claim 19, furthercomprising: placing the bag system with receptacle in the packaging; andpasteurizing the bag system and packaging.